Regulations establishing a binding administrative dispute resolution (ADR) process for the 340B program were rushed into place last December to defeat lawsuits, are fatally flawed legally and constitutionally, and should be struck down, the main U.S. trade association for drug
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The Biden administration plans to rescind a published but unimplemented Trump-era regulation that would peg Medicare Part B drug reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers get in similar countries. The widely criticized regulation
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California’s twice-postponed shift of Medicaid (Medi-Cal) managed care prescription drug benefits to Medi-Cal fee for service (FFS) is back on for Jan. 1, 2022, one year later than originally planned.
A similar high-stakes battle over Medicaid reimbursement for 340B-purchased drugs
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The clerk of the federal district court in Wilmington, Del., confirmed this morning that a judge did not rule that drug manufacturer AstraZeneca is not required to deliver 340B discounts drugs to an unlimited number of contract pharmacies. There were
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CORRECTION Thursday, Aug. 5, 2021, 8:15 p.m.—Earlier today, we misdescribed Novo Nordisk’s 340B contract pharmacy policy. Beginning on Jan. 1, 2021, Novo Nordisk stopped facilitating bill to/ship to distribution of 340B product to hospital contract pharmacies. We incorrectly said Novo
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Biopharmaceutical company Apellis has announced a limited distribution plan for Empaveli (pegcetacoplan), a newly approved treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, chronic, life-threatening blood disorder.
The U.S. Food and Drug Administration (FDA) approved Empaveli on
An upstate New York health center has sued the nation’s four major insulin manufacturers for allegedly conspiring to stop offering 340B pricing when covered entities use contract pharmacies.
Mosaic Health’s July 30 lawsuit claims that insulin manufacturers’ Sanofi, Eli
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Boehringer Ingelheim (BI) on Sunday became the seventh drug manufacturer to deny 340B pricing on its products when hospitals contract with pharmacies to dispense the medicines, hospitals reported yesterday.
BI this morning confirmed that it has begun denying 340B pricing
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340B covered entities dodged a bullet Sunday when U.S. Senate negotiators released the text of a $550 billion bipartisan infrastructure-spending bill. It did not contain Medicaid managed care “spread pricing” language that entities have been fending off since 2019. Entities
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Attorneys for the government and drug manufacturer Eli Lilly dueled over the legality of 340B contract pharmacy requirements during a hearing before a federal district judge in Indianapolis today.
Stakeholders are watching the Lilly case closely because, given how far
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